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The BBL™ Streptocard™ Acid Latex Test is a latex test system for the qualitative identification of Lancefield streptococcal groups A, B, C, F and G. The test is intended for use with streptococcus colonies that are β-hemolytic on blood agar.

β-hemolytic streptococci can be differentiated into Lancefield groups based on specific carbohydrate antigens.¹ Differentiation is necessary for clinical treatment and for epidemiological purposes.² For extraction of the group specific antigen prior to grouping a variety of methods have been used including hot acid,¹ hot formamide³ and enzyme extraction methods.^4,5 The BBL Streptocard Acid Latex Test is based on modified nitrous reagents,^6,7 which will rapidly extract the group antigens without the need for any incubation.

Initially, upon receipt, the laboratory should check each shipment or lot of material prior to use to verify the performance of the product.

Streptococci of known group reactivity should be subjected to the complete test procedure. The performance of the test is assessed by the presence of agglutination in one latex suspension only, with the other four suspensions showing a negative (no agglutination) reaction for each reference strain tested. This will evaluate both the efficacy of the extraction procedure and the specificity of each reagent.

The positive control procedure and negative control procedure should be tested each day of use. Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.

POSITIVE CONTROL – Shake each Test Latex and dispense 1 drop onto a separate circle of the card. Dispense 1 drop of Control + onto each of the five circles. Spread each mixture over the entire area of the circle, using a separate stick for each Test Latex. Rock the card manually for 1 min. Each of the five Test Latex should demonstrate obvious agglutination.

NEGATIVE CONTROL – Shake each Test Latex and dispense 1 drop onto a separate circle of the card. Prepare the Negative Control by adding extraction reagents to 12 x 75 mm test tube per steps 1, 2, 3 and 5 (Refer to section "Test Procedure" above). Dispense 1 drop of Negative Control onto each of the five circles on a reaction card. Spread each mixture over the entire area of the circle, using a separate stick for each Test Latex. Rock the card manually for 1 min. No obvious agglutination should be evident for any Test Latex suspension.

The BBL™ Streptocard™ Positive Control (Cat. No. 240965) contains a mixture of extracted antigen from streptococcal groups A, B, C, D, F and G with sodium azide as a preservative. This control may also be used to perform quality control when using the individual test latex reagents (see "Availability").

For in vitro Diagnostic Use.

Caution: This product contains natural rubber latex which may cause allergic reactions.

Do not use test components beyond the expiration date

WARNING: Toxic if swallowed. Corrosive, causes burns. When using do not eat or drink. Wear suitable protective clothing, gloves and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately.

Reagents contain sodium azide. Very toxic by inhalation, in contact with skin, and if swallowed. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

REAGENTS: Extraction Reagents 1 and 2 contain a mild irritant and a weak acid respectively. Avoid direct contact by wearing suitable protective equipment. If the material comes into contact with the skin, mucous membranes or eyes immediately wash the area by rinsing with plenty of water.

Do not allow reagents to become contaminated by allowing the dropper tip to touch the specimen on the reaction card. Ensure caps are securely fitted on reagent bottles after each use to prevent contamination and drying out of the reagents.

CARDS: Care should be taken not to finger-mark the test areas, since this may result in an oily deposit and improper test results.